Senior Specialist, Operations (Project Management)

Key Responsibilities

PAI and Filing Readiness

• Coordinate cross-functional Pre-Approval Inspection (PAI) and filing-readiness plans, including deliverables, owners, dependencies, due dates, evidence, and escalation paths.
• Maintain integrated readiness trackers and dashboards that provide accurate visibility to critical milestones, risks, gaps, decisions, and recovery actions.
• Facilitate readiness reviews, working sessions, and governance updates; document decisions and drive action closure with accountable owners.
• Partner with subject matter experts to support preparation and quality review of filing-related documents, inspection evidence, procedures, training records, and supporting materials.
• Identify schedule or compliance risks early and coordinate mitigation plans that protect filing and inspection-readiness objectives.

Project Portfolio Management

• Manage the functional project portfolio by maintaining a current inventory of projects, priorities, resource needs, interdependencies, benefits, risks, and status.
• Lead portfolio intake, prioritization, sequencing, and review processes using consistent criteria aligned with site strategy, capacity, compliance, and business value.
• Develop portfolio summaries and dashboards that enable timely decisions, resource alignment, and escalation of constraints.
• Coach project leads on project charters, scope, milestones, governance, risk management, action tracking, and closeout expectations.
• Promote disciplined project controls, data accuracy, and a single source of truth across portfolio tools and reporting routines.

Change Review Board Leadership

• Lead the Change Review Board (CRB) operating rhythm, including agenda development, intake review, meeting facilitation, decision documentation, and follow-up.
• Coordinate cross-functional assessment of proposed changes for scope, quality, regulatory, technical, operational, validation, supply, schedule, and resource impacts.
• Ensure change proposals are sufficiently defined for review and that decisions, conditions, owners, and required actions are clearly captured and communicated.
• Monitor the change portfolio through implementation and closure, escalating aging actions, unresolved dependencies, and risks to the appropriate governance forum.
• Continuously improve CRB standards, templates, metrics, and workflows to strengthen decision quality, speed, and accountability.

Incident Writing and Investigation Support

• Author and coordinate incident and deviation records in partnership with Operations, Quality, Engineering, Technical Operations, and other subject matter experts.
• Build clear, fact-based event narratives and support problem definition, impact assessment, root-cause analysis, corrective and preventive actions, and on-time record progression.
• Facilitate investigation working sessions, track information requests and approvals, and maintain visibility to investigation milestones and potential delays.
• Apply strong technical writing practices to ensure records are concise, accurate, traceable, and aligned with applicable procedures and cGMP expectations.

Project Scheduling and Operational Excellence

• Develop and maintain integrated project schedules that include activities, logic, dependencies, milestones, critical paths, constraints, and resource assumptions.
• Partner with workstream leads to update progress, evaluate schedule impacts, identify recovery options, and communicate forecast changes.
• Produce routine schedule and milestone reporting for project teams and governance forums, with emphasis on exceptions and decisions required.
• Support continuous improvement initiatives that strengthen planning, governance, cycle time, right-first-time performance, and execution reliability.
• Participate in site tier processes, gemba walks, readiness reviews, and other operational routines as assigned.

Core Competencies

• Project leadership and cross-functional facilitation.
• Portfolio governance, prioritization, risk identification, and executive communication.
• Integrated scheduling, dependency management, and critical-path thinking.
• Coaching and capability development.
• Technical writing, investigation support, and document quality.
• Ability to influence without direct authority and work effectively in a matrixed environment.
• High attention to detail, strategic thinking, adaptability, and commitment to data integrity.